On 5 August 2026, the Medical Device Authority (MDA) announced the upcoming implementation of the Hologram Security Label for registered medical devices.
The initiative aims to strengthen post-market surveillance, improve product traceability, and help ensure the authenticity of medical devices available in the Malaysian market.
The Hologram Security Label will also support consumers in identifying medical devices registered with MDA and help reduce the circulation of counterfeit and unregistered medical devices.
The initiative will be introduced progressively through collaboration between the Ministry of Health (MOH), MDA, and relevant industry stakeholders. It is expected to support the verification of medical device authenticity and strengthen enforcement against non-compliant products.
The official announcement on the implementation is scheduled to be made by the Minister of Health during the International Medical Device Exhibition and Conference (IMDEC) 2026 on 26 August 2026. Further details are expected to be provided by MDA following the announcement.
Read the full announcement here:
https://portal.mda.gov.my/index.php/announcement/1838-press-rele-implementation-of-the-hologram-security-label-for-medical-devices
Purpose of the Announcement
To announce the upcoming implementation of the Hologram Security Label for registered medical devices in Malaysia.
To strengthen post-market surveillance, improve product traceability, and support verification of medical device authenticity in the Malaysian market.
Scope of Application
This announcement is relevant to manufacturers, Authorized Representatives, importers, distributors, and other stakeholders involved in registered medical devices in Malaysia.
It is also relevant to consumers and healthcare stakeholders who may use the Hologram Security Label to identify medical devices registered with MDA.
Key Highlights
- MDA will introduce a Hologram Security Label for registered medical devices.
- The initiative aims to strengthen post-market surveillance and product traceability.
- The label will help consumers verify the authenticity and registration status of medical devices.
- The implementation will be introduced progressively in collaboration with MOH, MDA, and industry stakeholders.
- The official announcement is scheduled to be made during IMDEC 2026 on 26 August 2026.
- Further implementation details are expected following the official announcement.
Implications to Clients
Manufacturers and other relevant stakeholders are advised to take note of this upcoming initiative and monitor further announcements from MDA regarding the implementation requirements.
Clients should stay informed on the applicable medical devices, implementation timeline, labeling obligations, and any actions required from industry stakeholders.
Companies may need to review their internal processes for labeling, product traceability, inventory control, and post-market compliance once MDA releases further implementation details.
Effective Date
To be confirmed by MDA.
For Inquiries
For inquiries or support regarding medical device regulatory requirements in Malaysia, please contact sales@andamanmed.com.